PROCALLUS FIXATOR 90028C

GUDID 18032568861181

PROCALLUS SHORT FIXATOR KIT WITH ACTUATOR

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18032568861181
• NIH Device Record Key: 534d7217-ba23-40c8-b97a-96dbae016e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCALLUS FIXATOR
• Version Model Number: 1
• Catalog Number: 90028C
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568861181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18032568861181]

Moist Heat or Steam Sterilization

[18032568861181]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-19

On-Brand Devices [PROCALLUS FIXATOR ]

• 18053504367055: PROCALLUS FIXATOR HYBRID CONNECTION
• 18053504360902: DISTAL HUMERAL CLAMP
• 18032937168057: ARTICULATED BODY FOR HEMICALLOTASIS
• 18032568867268: PROCALLUS SYSTEM STERIBOX, EMPTY
• 18032568867251: PROCALLUS SYSTEM WITH ACTUATOR STERIBOX, EMPTY
• 18032568867244: PROCALLUS SYSTEM INSTRUMENT STERIBOX, EMPTY
• 18032568866599: SUPPLEMENTARY SCREW HOLDER CLAMP
• 18032568861303: ELBOW EXTENDED RANGE CLAMP
• 18032568861273: RADIOLUCENT ANKLE CLAMP
• 18032568861266: ARTICULATION LOCKING NUT FOR RADIOLUCENT ANKLE CLAMP
• 18032568861242: SELF-ALIGNING ARTICULATED BODY FOR PROCALLUS
• 18032568861235: SELF-ALIGN ARTIC BODY ASSEMBLY KIT FOR PROCALLUS
• 18032568861228: CENTRAL BODY FEMALE COMPONENT FOR SHORT PROCALLUS
• 18032568861211: CENTRAL BODY MALE COMPONENT FOR SHORT PROCALLUS
• 18032568861204: PROCALLUS SHORT ACTUATOR EXTENDS TO 2.75 CM
• 18032568861198: PROCALLUS SHORT CENTRAL BODY
• 18032568861181: PROCALLUS SHORT FIXATOR KIT WITH ACTUATOR
• 18032568861174: PROCALLUS SHORT FIXATOR KIT
• 18032568861167: ARTICULATED BODY FOR THE HIP FOR PROCALLUS
• 18032568861150: CENTRAL BODY FEMALE COMPONENT FOR LONG PROCALLUS
• 18032568861143: CENTRAL BODY MALE COMPONENT FOR LONG PROCALLUS
• 18032568861136: CENTRAL BODY FEMALE COMPONENT FOR STANDARD PROCALLUS
• 18032568861129: CENTRAL BODY MALE COMPONENT FOR STANDARD PROCALLUS
• 18032568861112: CENTRAL BODY LOCKING NUT FOR PROCALLUS
• 18032568861105: MICROMOVEMENT LOCKING NUT FOR PROCALLUS
• 18032568861099: PROCALLUS CLAMP SCREW
• 18032568861082: PROCALLUS LONG ACTUATOR EXTENDS TO 8 CM
• 18032568861068: PROCALLUS T-CLAMP
• 18032568861051: PROCALLUS STRAIGHT CLAMP
• 18032568861044: BUSH
• 18032568861037: PROCALLUS LONG BODY
• 18032568861020: PROCALLUS STANDARD BODY
• 18032568861013: PROCALLUS LONG FIXATOR KIT WITH ACTUATOR
• 18032568861006: PROCALLUS LONG FIXATOR KIT
• 18032568860993: PROCALLUS STANDARD FIXATOR KIT WITH ACTUATOR
• 18032568860986: PROCALLUS STANDARD FIXATOR KIT
• 18032568032703: RADIOLUCENT ANKLE PIN GUIDE
• 18032568032567: PROCALLUS ASSEMBLY KIT
• 18032568032550: TORBAY-GARCHES CLAMP TEMPLATE RADIOLUCENT
• 18032568032505: METAPHYSEAL CLAMP TEMPLATE
• 18032568032475: ANGLED CLAMP TEMPLATE
• 18032568032352: DRILL GUIDE DIAMETER 4.8 MM LENGTH 140 MM
• 18032568032345: SCREW GUIDE LENGTH 160 MM
• 18032568030624: TORBAY-GARCHES CLAMP
• 18032568030556: CLAMP COVER FOR ANGLED CLAMP
• 18032568030549: METAPHYSEAL CLAMP
• 18032568030518: ANGLED CLAMP
• 18053504369844: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369783: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504369776: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.